Job Title :
Quality Systems Director
We are seeking a seasoned Quality Systems Director to lead our global quality management system. As the chief architect of quality, you will be responsible for developing and implementing a strategic approach to ensure regulatory compliance across all processes and products worldwide.
Your role will involve leading the harmonization and standardization of quality processes across all manufacturing sites and business units. You will also oversee the management and validation of digital QMS platforms, establish key performance indicators to monitor system performance, and integrate risk management principles throughout quality processes.
You will be the primary expert during internal and external audits, ensuring that our quality systems are aligned with international regulations (FDA, EMA, ISO). Your experience in managing global quality systems in pharmaceutical, biotechnology, or medical device sectors is essential, as well as your deep knowledge of FDA 21 CFR, EudraLex, GxP regulations, and ISO standards.
To succeed in this role, you will require a university degree in Chemistry, Pharmacy, Science, or Engineering, with specific training in Quality. Over 10 years of progressive experience managing global quality systems is necessary, along with advanced skills in digital QMS platforms and computer system validation.
Our company values equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3 / 2007.
We offer a permanent contract, private health insurance, continuous training and professional development plan, and a stable and collaborative work environment in a leading industry company.
The selection process will include an initial contact via email or phone, followed by two formal interviews combining virtual and on-site formats. Throughout the process, we will maintain transparent and continuous communication.
#J-18808-Ljbffr
Management Expert • Madrid, Madrid, SPAIN